Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SpotLight/SpotLight Duo (with DLIR option)

K-Number: K230370 · 2023-10-13

ApplicantArineta , Ltd.
Decision Date2023-10-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SpotLight/SpotLight Duo (with DLIR option) is the device name listed in this FDA 510(k) record. The listed applicant is Arineta , Ltd.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K230370. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpotLight/SpotLight Duo (with DLIR option)?

SpotLight/SpotLight Duo (with DLIR option) is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Arineta , Ltd.. The 510(k) number is K230370.

When did SpotLight/SpotLight Duo (with DLIR option) receive FDA 510(k) clearance?

SpotLight/SpotLight Duo (with DLIR option) received FDA 510(k) clearance on 2023-10-13, under 510(k) number K230370.

Who is the listed applicant for SpotLight/SpotLight Duo (with DLIR option)?

The FDA 510(k) record lists Arineta , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpotLight/SpotLight Duo (with DLIR option)?

The FDA product code for SpotLight/SpotLight Duo (with DLIR option) is JAK.

Other records listing Arineta , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionK241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionK213465CardioGrapheK161066SpotLight CT

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑